Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19 (RUXO-COVID)

April 5, 2021 updated by: Vanderson Geraldo Rocha

Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clinicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
  • PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air.

Exclusion Criteria:

  • Symptom onset > 14 days;
  • Neutrophil count < 1,000/mm3;
  • Platelets < 50,000/mm3;
  • ICU care at enrollment;
  • On invasive mechanical ventilation at enrollment;
  • Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
  • Uncontrolled arterial hypertension;
  • Current or previous use of systemic immunosuppressive therapy in the last 30 days;
  • Pregnancy or lactation;
  • Estimated creatinine clearance < 30 mL/min or receiving CRRT or intermittent hemodialysis;
  • Allergy to ruxolitinib;
  • Active tuberculosis;
  • HIV seropositivity;
  • Prior history of progressive multifocal leukoencephalopathy;
  • Use of any JAK inhibitor in the last 30 days before study enrollment;
  • Not qualifying according to investigators' perception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
Other: Placebo
Placebo tablets P.O. b.i.d. for 14 days.
Experimental: Experimental Group - ruxolitinib
Ruxolitinib 5 mg PO b.i.d. for 14 days
Drug: Janus Kinase Inhibitor (ruxolitinib)
5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils < 500/mm3 or platelets <50,000/mm3.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
A composite outcome of death or ICU admission or mechanical ventilation at day 14.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A composite outcome of death or ICU admission or mechanical ventilation at day 28
Time Frame: 28 days
28 days
Time to treatment failure
Time Frame: 28 days
ICU admission, mechanical ventilation, death or consent withdrawal
28 days
Overall survival at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Cumulative incidence of ICU admission rate at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Cumulative incidence of mechanical ventilation at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Duration of hospital stay
Time Frame: 28 days
28 days
Duration of ICU stay
Time Frame: 28 days
28 days
Duration of mechanical ventilation
Time Frame: 28 days
28 days
Duration of non-invasive ventilation
Time Frame: 28 days
28 days
Secondary hemophagocytic syndrome rate
Time Frame: 28 days
28 days
Cumulative incidence nosocomial infection rate at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Incidence of discontinuation of oxygen supplementation at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Rate of grade 1-2 and 3-5 emerging adverse events at day 28
Time Frame: 28 days
28 days
Cumulative dose of methylprednisolone at days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in PaO2/FiO2 ratio from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in d-dimer levels [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in ferritin levels [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in C reactive protein levels [mg/L] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in alanine aminotransferase [U/L] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in creatinine levels [mg/dL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in glucose levels [mg/dL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in hemoglobin levels [g/dL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in prothrombin time ratio from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in partial thromboplastin time ratio from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in bilirubin [mg/dl] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in CPK-MB [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in troponin [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in ADAMTS-13 [%] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in von Willebrand multimeters from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in E-selectin levels [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in P-selectin levels [ng/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in endothelin [fmol/mL] from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in circulating microparticles from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days
Change in thromboelastography from baseline to days 14 and 28
Time Frame: 14 and 28 days
14 and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderson Geraldo Rocha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 32894720.3.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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